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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Authoritative data base
Title:
NTP study for 121-69-7
Year:
2012
Bibliographic source:
NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Study obtained from NTP
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethylaniline
EC Number:
204-493-5
EC Name:
N,N-dimethylaniline
Cas Number:
121-69-7
Molecular formula:
C8H11N
IUPAC Name:
N,N-dimethylaniline
Details on test material:
- Name of test material (as cited in study report): N,N-dimethylaniline
- Substance type: Organic
- Physical state: liquid

Test animals

Species:
other: mice
Strain:
CD-1

Administration / exposure

Route of administration:
oral: gavage
Type of inhalation exposure (if applicable):
not specified
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6-13 days
Duration of test:
days 6-13 of gestation
No. of animals per sex per dose:
Fifty pregnant CD-1 mice
Control animals:
not specified
Details on study design:
new short-term in vivo animal bioassay.In this assay, pregnant mice are dosed with the test agent in mid-pregnancy and allowed to go to term.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
birth weight, neonatal growth, and survival of pups as indicators of developmental toxicity

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
365 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
N,N-Dimethylaniline had no toxic effect in the dams or in their offspring for the parameters assayed.
Executive summary:

N, N-Dimethylaniline was evaluated for developmental toxicity in a proposed new short-term in vivo animal bioassay. In this assay, pregnant mice are dosed with the test agent in mid-pregnancy and allowed to go to term. Observations are then made on litter size as well as the birth weight, neonatal growth, and survival of pups as indicators of developmental toxicity. Fifty pregnant CD-1 mice were given 365 mg/kg/day N,N-dimethylaniline in corn oil by gavage on days 6-13 of gestation and were allowed to deliver. N,N-Dimethylaniline had no toxic effect in the dams or in their offspring for the parameters assayed.